Bioprocess development engagement

Detailed client case studies will be published here as they are cleared for release. In the meantime, these are the engagements Z2 most often supports – and the questions each one answers.

CLD strategy / programme review

The question: Is our cell line strategy right for this molecule, and will the clone hold up?

  • Host/vector strategy, screening and clone selection
  • Stability and clonality evidence
  • Troubleshooting and independent CLD programme review

Upstream development & optimisation

The question: How do we raise titre and consistency, and will the process scale?

  • Media/feed optimisation and bioreactor development
  • Scale-up/down and robustness
  • Upstream CMC process understanding

Technology transfer

The question: Can the receiving site reproduce our process?

  • CLD/upstream knowledge transfer
  • Gap assessment and comparability
  • Receiving-site/CDMO readiness

Technical due diligence & CMC regulatory review

The question: What are the technical risks before we invest, partner or file?

  • Independent technical assessment and CMC risk review
  • Scientific support for IND/BLA and regulatory documentation
  • Red-flag reporting

Laboratory & capability establishment

The question: What does it take to stand up a working development lab?

  • CLD/bioprocess laboratory set-up and equipment
  • Workflows, qualification and SOPs
  • Operational readiness

Biosafety, GMO & compliance readiness

The question: Are we ready – legally and practically – for GM work?

  • Risk assessments and GMO/containment
  • COSHH/BioCOSHH and H&S
  • Associated compliance documentation

Investment & fundraising support

The question: Will our technical case stand up to funders and investors?

  • Scientific support for grants and investor materials
  • Technical due diligence
  • Investment-readiness assessment

Have a similar challenge? Talk to us about your programme.

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Whether you are designing a CLD programme, stuck on an upstream process, preparing for technology transfer, or assessing a biologics asset before you commit.